FDA Inspection 1009733 — Mega Pro International
The FDA completed an inspection of Mega Pro International on April 25, 2017 in Saint George, UT. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 25, 2017
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Saint George, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15605 | 21 CFR 111.165(c) | Product received - quarantine |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 15939 | 21 CFR 111.105(g) | Quality control - reserve samples |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |